Endo Exam 1: Lewis ED (Simplified)

Types of Sexual Dysfunction in Men

• Erectile dysfunction (impotence) → Failure to achieve a penile erection suitable for satisfactory sexual intercourse

Etiology

• _____ ED → dz that decrease vascular flow

• _____ ED → Low testosterone levels

• Psychogenic → anxiety, sedation, Alzheimer’s, HYPOhyroidism, mental d/os

• Habits → _____ and _____

• Meds

Organic, Secondary, smoking, EtOH intake

Drug Class + Special Notes that CAUSE ED

• Anticholinergics (KNOW)

  • _____

  • _____ and _____ (_____, _____, _____, _____) PSFF

• _____ (decreased libido)

• _____ or drugs with antiandrogenic effects (decreased libido)

• _____

• _____ reductase inhibitors

1st gen AHs, TCAs, SSRIs, Paroxetine, Sertraline, Fluvoxamine, Fluoxetine, DA antagonists, Estrogens, CNS depressants, 5-alpha

Agents that decrease penile blood flow (KNOW)

• _____ ↓ intravascular volume → decrease penile arteriolar flow

• _____ (large doses) → estrogenic effects, ↑ potential to ↓ libido, cause ED

• Limited data with loops, _____ most implicated

• _____, _____, _____

  • _____, _____, _____ (NCL) → less potential to cause ED

• ACEi, ARB, terazosin, doxazosin, CCBs preferred for HTN in ED

Diuretics, Spironolactone, thiazides, Propranolol, Atenolol, Metoprolol, Nebivolol, Carvedilol, Labetalol

Treatment Ladder

• 1 — _____ / risk-factor management

  • Heart-healthy lifestyle; address hypertension, CAD, dyslipidemia, diabetes, smoking, and excessive ethanol intake

• 2 — 1st-line pharmacotherapy

  • _____: _____, _____ (_____® ODT), _____, or _____.

• 3 — 2nd-line options

  • _____ (VED, OTC) or intracavernosal _____ for selected patients who do not respond to oral therapy.

• 4 — Testosterone only when indicated

  • Use for _____ confirmed by low serum _____—not for isolated erectile dysfunction. (No testosterone if testosterone levels are NORMAL)

Lifestyle, PDE5is, Sildenafil, Vardenafil, Staxyn, Tadalafil, Avanafil, Vacuum Erection Device, Alprostadil, symptomatic hypogonadism, testosterone

PDE5-I

• Sildenafil (_____®)

  • More _____ effects than tadalafil/avanafil

• Vardenafil (_____®, _____® ODT)

  • DO NOT USE if _____ or taking _____

  • More _____ effects than tadalafil/avanafil

• Tadalafil (_____®) → take it _____ (all the others are before intercourse)

  • More _____

  • Indicated for ED + _____

• Avanafil (_____®)

Viagra, visual, Levitra, Staxyn, QT prolongation, antiarrhythmics, visual, Cialis, once daily, back pain, BPH, Stendra

Adverse Effects & Monitoring

• Expected / agent-specific

  • Common: headache, flushing, dyspepsia, nasal congestion, dizziness.

  • Sildenafil/Vardenafil: more visual effects because of PDE6 inhibition.

  • Tadalafil: more back pain, limb pain, and myalgia.

  • Avanafil: generally well tolerated; less dyspepsia

  • All agents can cause _____; monitor especially with antihypertensives or alpha-blockers

• Urgent counseling points

  • Sudden vision loss → _____ PDE5 inhibitor and obtain medical evaluation.

  • Sudden hearing loss → _____ PDE5 inhibitor and seek medical evaluation.

  • Priapism → emergency department evaluation.

  • Palpitations/dizziness with vardenafil → assess _____ and consider ECG/QT evaluation.

  • Review BP, pulse, adverse effects, and erectile response at follow-up

Hypotension, stop, stop, BP

Nonarteritic anterior ischemic optic neuropathy (NAION)

• “stroke of the eye”

• May develop _____ to _____ or _____ after the _____

• Decreased blood flow to the optic nerve → sudden unilateral decrease in vision

• May lead to _____ → FDA warning

• Patients at risk of NAION

  • _____, macular degeneration, diabetic retinopathy, _____, or _____

  • eye _____

  • _____ years or more

  • _____

6 hours, months, years, 1st dose, permanent vision loss, glaucoma, dyslipidemia, HTN, surgery/trauma, 50, smokers

 If sudden vision loss in one eye while on PDE5 inhibitor

• evaluate for NAION → if NAION present → _____

STOP PDE5i

PDE5 Inhibitors: C/Is

• Absolute / major concerns

  • C/I with _____ by any route, scheduled or intermittent.

  • Nitrates should be withheld for _____ after sildenafil, vardenafil, or avanafil; _____ after tadalafil.

  • Vardenafil: avoid congenital _____ or class IA / III antiarrhythmics.

  • Use caution in patients with _____ because sexual activity itself may carry cardiac risk

nitrates, 24 hours, 48 hours, prolonged QT, CVD

PDE5 Inhibitors

• Important interaction checks

  • _____: additive hypotension is possible; stabilize BP, use low alpha-blocker doses, and separate administration when appropriate.

  • Strong CYP3A4 inhibitors can substantially increase PDE5 exposure → lower starting doses.

  • CYP3A4 inducers can reduce exposure → clinical response may be reduced.

  • Do not use with riociguat (_____®) because of _____ risk

Alpha-Blockers, Adempas, hypotension

Red flag: A patient taking _____ is not a routine PDE5 candidate. The interaction can produce _____.

NG, sudden and severe hypotension

High Risk/C/I for PDE-Is KNOW!!!

• Unstable/Refractory _____

• _____

• _____

• Severe _____ (Class IV)

• Recent _____ within past _____

• Moderate-Severe _____ Disease

• High-Risk _____

• _____ Cardiomyopathy

Angina, Uncontrolled HTN, AFib, CHF, MI/Stroke, 2 weeks, Valvular Heart, Cardiac Arrhythmias, Obstructive Hypertrophic

PDE5 Inhibitor Counseling: Make the Prescription Work

• Sexual stimulation is still required; these agents do not create an erection w/o sexual arousal.

• Allow adequate time for effect. Some patients need a full hour even though onset can occur earlier.

• If no response to first dose, should continue with the PDE5 inhibitor for at least _____ before failure is declared, as increasing success rates are reported with sequential dose administration

• Sildenafil and Vardenafil → _____, fatty meal can delay absorption

• Tadalafil and Avanafil → take w/o regard to meals.

• _____® over _____® ODT IF on _____, take ODT _____

• Tx of concomitant medical illnesses that contribute to erectile dysfunction (eg, DM, HTN, and hypogonadism) should be optimized

• Avoid excessive _____ intake because of additive hypotension/drowsiness risk.

• Do not self-escalate doses. Higher-than-recommended doses have not consistently improved erectile response and increased adverse effects.

• Ask about nitrate use every time therapy is initiated or changed

7-8 doses, take on empty stomach, Levitra, Staxyn, alpha blocker, w/o water, EtOH

When a PDE5 Inhibitor “Doesn’t Work”

• First verify use: correct dose/timing, adequate sexual stimulation, adequate number of attempts, and no major food/drug interaction.

• Do not assume failure after one poorly timed dose.

• Switching to _____ is possible, but routine switching after nonresponse is described as controversial.

• Consider _____ when coordinating on-demand dosing is difficult; recognize higher cost.

• Selected patients may receive combination strategies involving tadalafil and another PDE5 inhibitor or alprostadil, but these approaches require clinician oversight.

• Testosterone supplementation may improve PDE5 response in older patients with confirmed late- onset hypogonadism.

• Clinical pharmacy checkpoint: Before recommending “stronger therapy,” determine whether the patient has actually had an adequate therapeutic trial

another PDE5i, Tadalafil daily

Second-Line Option: Vacuum Erection Device (VED)

• Counseling essentials

  • Noninvasive device with a pump, cylinder, and constriction band/ring.

  • Onset: about 3–20 minutes; experienced users may achieve faster onset.

  • Band/ring maintains erection by reducing venous outflow.

  • Choose a device with a pop-off safety valve to reduce excessive vacuum pressure.

  • Limit constriction-band use to ≤30 minutes

KNOW

Second-Line Option: Vacuum Erection Device (VED)

• Safety / patient selection

  • Possible penile pain, bruising, numbness, coolness, discoloration, or hinge-like erection.

  • C/I with _____, Hx of _____ erections, or severe penile curvature.

  • Use cautiously with _____ because of bruising risk.

  • Can be combined with PDE5is or intracavernosal alprostadil in selected patients

sickle cell disease, prolonged, warfarin

Second-Line Pharmacotherapy: Alprostadil

• How to use safely

  • Initial dose should be administered under healthcare-professional supervision.

  • Typical dose: 2.5 mcg _____; usual range 5–40 mcg; maximum 60 mcg.

  • Inject over 5–10 seconds using aseptic technique.

  • Do not exceed one injection/day and three injections/week; maintain a 24-hour interval between doses.

  • Patient requires training in injection technique

Intracavernosally

Second-Line Pharmacotherapy: Intracavernosal Alprostadil

• Key adverse effects / exclusions

  • Penile pain, hematoma, hypotension, and priapism.

  • Repeated injections can rarely cause fibrotic nodules.

  • If priapism develops → _____.

  • Use the _____ effective dose in older adults.

  • Do not use in sickle cell disease, leukemia, multiple myeloma, severe coagulopathy, severe CVD, and poor manual dexterity

emergency, lowest

Testosterone: When Is It Appropriate?

• Indication: symptomatic primary, secondary, or mixed hypogonadism confirmed with low serum testosterone.

• Testosterone should not be used for _____ when serum testosterone is _____.

• Consider free testosterone when total testosterone is borderline (ie 200-300 ng/dL).

• Observable improvement can take weeks to months; a _____-month trial period

isolated ED, normal, 3-6

Testosterone Replacement: Monitoring & Counseling

• Monitor 

  • Serum testosterone according to formulation and clinical response.

  • Hematocrit (blood clotting); _____ if Hct ≥_____% (_____ risk → watch for _____)

  • Serum lipids, hepatic transaminases, and prostate-specific antigen.

  • BP and clinical signs of edema.

  • Clinical Sxs: libido, mood, erectile function, and adverse effects

D/C testosterone, 55, clotting, ankle swelling

Testosterone Replacement: Monitoring & Counseling

• High-yield precautions

  • May worsen lower urinary tract sxs in _____.

  • C/I in untreated _____ and in men with _____.

  • Transdermal products: prevent inadvertent transfer to women/children; wash hands after application and be covered

  • _____ can produce supraphysiologic peaks and mood swings/polycythemia. (levels checked regularly)

  • _____ has a pulmonary oil microembolism(POME)/anaphylaxis warning and restricted administration requirements

BPH, prostate cancer, breast cancer, IM testosterone cypionate, Testosterone undecanoate injection

Case 1 — The Nitrate Question

Patient: A 66-year-old man requests sildenafil for ED. Medication list includes sublingual nitroglycerin PRN for angina and tamsulosin for BPH.

• What is the most important medication-safety issue?

PDE5I with Nitrates (NG)

Case 1 — The Nitrate Question

Patient: A 66-year-old man requests sildenafil for ED. Medication list includes sublingual nitroglycerin PRN for angina and tamsulosin for BPH.

• What should the pharmacist recommend regarding sildenafil? How does the tamsulosin issue differ from the nitrate issue? What counseling point should be documented?

Tamsulosin is an alpha-blocker and NOT C/I but a vasodilator, lowering BP (needs stabilization and careful timing)

Case 2 — “Sildenafil Didn’t Work”

Patient: A 52-year-old man took sildenafil 50 mg once, immediately after a large high-fat dinner, and reports no effect. He wants a higher dose.

• What should the pharmacist assess before recommending dose escalation?

Correct administration/timing

Case 2 — “Sildenafil Didn’t Work”

Patient: A 52-year-old man took sildenafil 50 mg once, immediately after a large high-fat dinner, and reports no effect. He wants a higher dose.

• Which counseling issue is most likely relevant?

Take on empty stomach

Case 2 — “Sildenafil Didn’t Work”

Patient: A 52-year-old man took sildenafil 50 mg once, immediately after a large high-fat dinner, and reports no effect. He wants a higher dose.

• Would 200 mg sildenafil be an appropriate routine recommendation?

• What alternative PDE5 strategy could be considered if timing is the main barrier?

No, need trial of 7-8 doses, Tadalafil daily

1. Which PDE5 inhibitor has the longest duration?

   1. _____

2. Which PDE5 inhibitor has the fastest labeled onset?

   1. _____

3. What is the absolute “do not combine” drug class?

   1. _____

4. What is the emergency adverse effect to recognize?

   1. _____

5. Which PDE5 inhibitor raises a unique QT-prolongation concern?

   1. _____

6. When should testosterone be used?

   1. When you have _____

7. Can patients drink grapefruit juice with PDE5 inhibitors?

   1. _____

8. What are Revatio®, Adcirca®, and Alyq®? → NOT USED FOR ED, IT’S FOR _____!!

   1. Revatio® → _____

   2. Adcirca® → _____

   3. Alyq® → _____

Tadalafil, Avanafil, Nitrates (NG), NAION, Verdenafil, Low testosterone, No (grapefruit juice blocks CYP3A4), Pulmonary Arterial HTN (PAH), Sildenafil, Tadalafil, Tadalafil